Dear Healthcare Professional Letters
Updates to the Instructions for Use and Patient Manual for HeartWare™ Ventricular Assist Device (HVAD™) System
Audiences
Healthcare professional
Industry member
Product type
Medical devices
2 November 2023
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A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of upcoming updates to the Instructions for Use (IFU) and Patient Manual (PM) for the HeartWare™ Ventricular Assist Device (HVAD™) System. These updates include clarification on the conditions under which an HVAD™ [Controller Fault] alarm may sound and the recommended troubleshooting actions as well as instructions relating to the useful life of the HVAD™ system components. Healthcare professionals are advised to review the updated IFU and PM and to share the information with their patients as needed. Please refer to the letter for details.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.
Step 1: Select your profession under ‘For Healthcare Professionals’.
Step 2: Click on ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.